Efficacy of Pattern Respiratory PNF Associated Aerobic Training on Lung Volumes and 6MWT Test in Parkinson Individuals

Parkinson Disease Clinical Trial

Official title:

Efficacy of Pattern Respiratory Proprioceptive Neuromuscular Facilitation Associated With Aerobic Training on the Volumes, Lung Capacity and Six-minute Walking Test in Individuals With Parkinson: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02600052
• Other study ID #: 06704028420
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: June 22, 2016
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: January 2016
• Source: Universidade Federal de Pernambuco
• Contact: Carlos Rego Barros
• Phone: +55 81 21268496
• Email: carlosregobarros[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

INTRODUCTION:

Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall PD patients, mostly there is associated respiratory disorders. The respiratory impairment may be due by postural changes, limiting the flexibility and expandability of the chest wall causing decreased lung volumes and flows. So the exercise Proprioceptive Neuromuscular Facilitation (PNF) is a tool designed to reduce the changes in respiratory function, the commitment of the respiratory muscles, and allows greater flexibility of the chest wall, reducing the rigidity of the rib cage. To evaluate the effects of respiratory pattern of Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary ventilation, compartmental volumes of diaphragmatic mobility and functional capacity in patients with Parkinson's disease.

METHODS:

The study is a clinical trial randomized, in which participants to be elected for the study should present diagnosis of PD, staging of disease between II and III according to Hoehn and Yahr. Initially, the participants will undergo the collection of data on medical history, assessment of pulmonary function by spirometry and respiratory muscle strength measured by the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental distribution of the volume of the chest wall by hemithorax by Plethysmography Optoelectronic; Quantify the mobility of the right diaphragm in total lung capacity for maneuver and during the current volume by ultrasonography. After the evaluation, participants will undergo intervention which will consist of three stages: first occur first session of the PNF later aerobic training for 30 minutes, ending with one PNF session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individuals with stage II and III between the Hoehn and Yahr classification;

• minimum score of 28 on the Mini Mental Examination for Parkinson.

Exclusion Criteria:

• individuals with rheumatologic or orthopedic diseases or deformities / abnormalities in the spine that compromise the respiratory mechanics;

• respiratory comorbidities;

• history of smoking;

• history of thoracic or abdominal surgery;

• clinical instability characterized by infections and / or hemodynamic defined as greater than 150 bpm heart rate or systolic blood pressure less than 90 mmHg;

• Not present exchange of the drug in the last 30 days.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• PNF
RESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION

Device:
• treadmill
AEROBIC TRAINING

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

ALIVERTI A, PEDOTTI A. Opto-electronic Plethysmography. v. c, 2002.

Carvalho A, Barbirato D, Araujo N, Martins JV, Cavalcanti JL, Santos TM, Coutinho ES, Laks J, Deslandes AC. Comparison of strength training, aerobic training, and additional physical therapy as supplementary treatments for Parkinson's disease: pilot study. Clin Interv Aging. 2015 Jan 7;10:183-91. doi: 10.2147/CIA.S68779. eCollection 2015. — View Citation

Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Mundi C, Caltagirone C, Carlesimo GA. Mini mental Parkinson test: standardization and normative data on an Italian sample. Neurol Sci. 2013 Oct;34(10):1797-803. doi: 10.1007/s10072-013-1342-8. Epub 2013 Mar 12. — View Citation

Isella V, Mapelli C, Morielli N, De Gaspari D, Siri C, Pezzoli G, Antonini A, Poletti M, Bonuccelli U, Picchi L, Napolitano A, Vista M, Greco A, Appollonio IM. Validity and metric of MiniMental Parkinson and MiniMental State Examination in Parkinson's disease. Neurol Sci. 2013 Oct;34(10):1751-8. doi: 10.1007/s10072-013-1328-6. Epub 2013 Feb 20. — View Citation

Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. Review. — View Citation

MOORE, V. C. Spirometry: Step by step. Breathe, v. 8, n. 3, p. 233-240, 2012

Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. — View Citation

Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. English, Portuguese. — View Citation

Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PRESSURE RESPIRATORY MAXIMAL	BY MANOVACUOMETER	1 MONTH	Yes
Primary	LUNG VOLUME	BY OPTOELECTRONIC PLETHYSMOGRAPHY	1 MONTH	Yes
Primary	WALKING DISTANCE, VO2, VCO2	SIX-MINUTE WALK TEST PLUS CÓRTEX	1 MONTH	Yes
Secondary	DIAPHRAGM MOBILITY	ULTRASOUND	1 MONTH	Yes
Secondary	DIAPHRAGM THICKNESS	ULTRASOUND	1 MONTH	Yes